Randomized Clinical Trial
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 21, 2018; 24(35): 4077-4085
Published online Sep 21, 2018. doi: 10.3748/wjg.v24.i35.4077
Usefulness of the clip-flap method of endoscopic submucosal dissection: A randomized controlled trial
Hiromitsu Ban, Mitsushige Sugimoto, Taketo Otsuka, Masaki Murata, Toshiro Nakata, Hiroshi Hasegawa, Osamu Inatomi, Shigeki Bamba, Akira Andoh
Hiromitsu Ban, Mitsushige Sugimoto, Taketo Otsuka, Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Shiga 520-2192, Japan
Masaki Murata, Toshiro Nakata, Hiroshi Hasegawa, Osamu Inatomi, Akira Andoh, Department of Gastroenterology, Shiga University of Medical Science Hospital, Shiga 520-2192, Japan
Shigeki Bamba, Division of Clinical Nutrition, Shiga University of Medical Science Hospital, Shiga 520-2192, Japan
Author contributions: Ban H, Sugimoto M, Otsuka T, Murata M, Nakata T, Hasegawa H, Inatomi O, Bamba S and Andoh A designed this study; Ban H was the clinical investigator with more patients recruited and treated; Hasegawa H, Inatomi O, Bamba S and Andoh A, took part in trial coordination and monitoring; Ban H, Sugimoto M, Otsuka T, Murata M, Nakata T, Hasegawa H collected the data and their management; Ban H, Sugimoto M contributed to the statistical analysis; Ban H, Sugimoto M analyzed and interpreted the data; Ban H, Sugimoto M drafted the manuscript and made the final approval of the version to the published.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of Shiga University of Medical Science.
Clinical trial registration statement: This study is registered on Universal hospital Medical Information Network (UMIN000018199).
Informed consent statement: All study participants provided written informed consent prior to study enrolment.
Conflict-of-interest statement: None of the authors have any conflicts of interest related to this study.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The CONSORT 2010 Statement have been adopted.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Mitsushige Sugimoto, MD, PhD, Associate Professor, Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Seta Tsukinowa-cho, Otsu, Shiga 520-2192, Japan. sugimo@belle.shiga-med.ac.jp
Telephone: +81-77-5482618 Fax: +81-77-5482618
Received: June 21, 2018
Peer-review started: June 21, 2018
First decision: July 31, 2018
Revised: August 5, 2018
Accepted: August 24, 2018
Article in press: August 24, 2018
Published online: September 21, 2018
Processing time: 90 Days and 22.2 Hours
Core Tip

Core tip: We conducted a prospective study to investigate efficacy of the clip-flap method of endoscopic submucosal dissection (ESD) for early-stage gastric tumor. Recently, although the efficacy of the clip-flap method for ESD of large colorectal tumors is shown, we failed to show advantage of clip-flap method in efficacy or safety compared with the conventional method. Efficacy of clip-flap method-assisted ESD for gastric tumors may be limited, especially in cases with large size of tumor and with difficulty to make mucosal flap.